Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients

Stroke Clinical Trial

Official title:

Effects of Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients With Severe Upper Extremity Hemiparesis: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03635008
• Other study ID #: B-1805/468-002
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Won-Seok Kim, MD, PhD
• Phone: +82317877735
• Email: wondol77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke.

In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age: 18-85 years old

• Ischemic or Hemorrhagic stroke confirmed by the MRI or CT

• First-ever stroke

• < 3 months after stroke

• Unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)Shoulder Abduction Finger Extension (SAFE) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)Fugl Meyer Assessment score in the affected upper extremity is 25 or under 25. (3)No response in the motor evoked potential recorded on the affected extensor carpi radialis muscle,

Exclusion Criteria:

• recurrent stroke

• history of the other brain injury (e.g. traumatic brain injury)

• poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15).

• Poor cooperation due to delirium or problems in the consciousness

• Uncontrolled or unstable medical conditions.

• Pregnant

• Scalp problems which interfere with the tDCS application

• Robotic arm training can not be applied due to the unstable sitting posture or head control, or arm pain.

• Metals in the head (e.g. clip, coil)

• Cardiac pacemaker or cochlear implants

Related Conditions & MeSH terms

• Neurological Rehabilitation
• Recovery of Function
• Stroke
• Transcranial Direct Current Stimulation

Intervention

Device:
• tDCS
Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. For the sham tDCS the stimulation will be applied for just first 30 seconds.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea)

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA) scores of the upper extremity	range: 0 (worst) -66 (best)	Change from Baseline FMA at 2 weeks
Secondary	Korean version of modified Barthel Index (K-MBI)	range: 0 (worst) -100 (best)	Change from baseline K-MBI at 2 weeks
Secondary	Korean version of modified Barthel Index (K-MBI)	range: 0 (worst) -100 (best)	Change from baseline K-MBI at 6 weeks
Secondary	Brunnstrom stage (B-stage) of arm	range: 1(worst) -6 (best)	Change from baseline B-stage at 2 weeks
Secondary	Brunnstrom stage (B-stage) of arm	range: 1(worst) -6 (best)	Change from baseline B-stage at 6 weeks
Secondary	Box and Block Test (BBT)	maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function	Change from baseline BBT at 2 weeks
Secondary	Box and Block Test (BBT)	maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function	Change from baseline BBT at 6 weeks
Secondary	Modified Ashworth Scale	to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)	2 weeks after baseline
Secondary	Modified Ashworth Scale	to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)	6 weeks after baseline
Secondary	Manual muscle power test	3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest).	2 weeks after baseline
Secondary	Manual muscle power test	3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest).	6 weeks after baseline
Secondary	Laterality Index	Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography	2 weeks after baseline
Secondary	Laterality Index	Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography	6 weeks after baseline
Secondary	Fugl-Meyer Assessment (FMA) scores of the upper extremity	range: 0 (worst) -66 (best)	Change from Baseline FMA at 6 weeks